Devices and methods to conform and treat body cavities

Abstract

Devices and methods are provided to administer treatment to walls of either naturally occurring cavities or cavities generated by the resection of tissue such as tumors, and to ensure better tissue contact of the device resulting in more effective treatment methods. A device may include a rigid outer surface, that can be brought into firm engagement with the tissue of body cavities by applying suction through channels in the head and stem portion of the device. Methods to treat conformed body cavities tissues may use individual or combination of physical agents including radiation, heat, cold, electrofrequency or chemical agents, such as thrombolytic and cytostatic medications. Systems may include devices described in the invention and sources to provide suction and / or other described means to enhance body tissue conformance to a non-deformable and / or non-distensible body.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Ser. No. 60 / 565,811 filed Apr. 26, 2004, which application is fully incorporated herein by reference.BACKGROUND [0002] 1. Field of Invention [0003] This invention relates generally to methods and devices for applying physical agents such as radiation, heat, cold, electrofrequency or chemical agents, such as thrombolytic and cytostatic medications, to body cavities, including natural body cavities and wound cavities resulting from resection of a tumor, and more particularly to methods and devices to ensure tissue contact and conformance to a non-deformable body introduced to a wound cavity, resulting from resection of a tumor. [0004] 2. Description of the Related Art [0005] One method of treating cancer, and breast cancer in particular, is radiotherapy. Conventionally, a “radical” dose of 50 Gy of radiation is delivered to the breast over a period of about one month, and a further five days are...

AI Technical Summary

Benefits of technology

[0016] Another object of the present invention is to provide improved methods and systems for conformance of walls of a body cavity to a treatment device at least partially positioned in the body cavity.

Problems solved by technology

Because of the curvature of the chest wall, it is very difficult to exclude the radio-sensitive tissues of the underlying lung.

The reason for irradiating such large volumes of tissue is that it is difficult to locate the tumor bed accurately after closing and healing of the surgical wound and generous margins are necessary to ensure proper coverage of the tumor bed.

In addition, it is difficult technically to irradiate a very limited part of the breast due to the constraints of the beam delivery.

An alternative technique which has been used to implant the tumor bed with radioactive iridium wires in theatre, but this has the serious draw-back of increasing theatre time markedly, and exposing the theatre staff to radiation.

Conventional radiotherapy treatment of the breast may lead to undesirable damage to large areas of tissue, and therefore the total dosage of radiation that can be delivered to the malignant tissue, is limited.

In the latter case, the tumor bed to be irradiated must be exposed and manipulated to accommodate the electron applicator, which is tedious or imprecise.

It remains an ongoing problem to be able to control the intensity, distribution and depth of radiation applied to the tissue to be irradiated, while protecting healthy tissue and minimizing the dose of radiation applied to it.

These devices present major problems in ensuring, that the inflation of the device is uniform with no inclusions e.g. air bubbles and that the device does not undergo conformal changes between implantation and treatment administration, such as for example by perforation and deflation during surgical manipulation.

While the same reduction in recurrence can be achieved by a wider surgical resection, this is undesirable as it leaves, notably in the case of breast cancer, a cosmetically unacceptable deformity.

In methods and devices, where a physical agent is applied during or after surgery in a wound cavity, there is a problem to ensure, that the device is in contact with the wound surface at all times during radiation and not displaced by wound fluids such as hematoma or seroma or insertional artifacts such as air bubbles which would lead to undesirable low dosages delivered to the tissues displaced.

Yet another problem with postoperatively placed devices is placement into the correct position, which is currently estimated by imaging and aiming the device at the putative resection cavity.

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